Enhancing Adherence by Building Online Communities
Primary Purpose
Type 2 Diabetes, Coronary Artery Disease, Obesity
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Stepping Up to Health
Sponsored by

About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring heart, weight, Overweight, bmi, diabetes, type 2, diabetic, walk, walk*, diab*, obese, exercise, activity, coronary, pedometer
Eligibility Criteria
Inclusion Criteria:
- Must have one or more of the following: Coronary artery disease (CAD); BMI 25 or higher; Type 2 diabetes
- Must be sedentary, defined by less than 150 minutes of self-reported activity per week
- Must be 18 or older
- Must have access to a computer with an Internet connection, a USB port, and Windows 2000 (latest service pack), XP or Vista
- Must be a regular email user (checking weekly)
- Must be able to communicate in English
Exclusion Criteria:
- Pregnant
- Cannot walk a block (self-report)
- Not competent to sign consent
- Unable to obtain medical clearance from a treating physician (primary care, cardiologist, endocrinologist)
- Type 1 diabetes
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
Stepping Up to Health only
Stepping up to Health PLUS online message boards to talk with other participants
Outcomes
Primary Outcome Measures
Total steps
Secondary Outcome Measures
dropout rate
days and hours pedometer worn
login frequency
upload frequency
content of posts (qualitative)
Full Information
NCT ID
NCT00729040
First Posted
August 1, 2008
Last Updated
January 27, 2009
Sponsor
Robert Wood Johnson Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00729040
Brief Title
Enhancing Adherence by Building Online Communities
Official Title
Enhancing Adherence to an Internet-Mediated Walking Program by Building Online Communities
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Robert Wood Johnson Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether online peer support will increase adherence to an internet-based pedometer walking program.
Detailed Description
Stepping Up to Health with eCommunities is a study that takes what we already know about motivating sedentary, chronically ill people to walk, and begins to explore what it takes to keep people motivated to exercise over time: the ability to self-monitor behavior with accurate ecological momentary assessments.
We have theorized that peer support, monitoring and competition are ways in which people can stay motivated to meet their walking goals; thus, we have built into this intervention online forums for participants to communicate with each other and garner support, as well as a pilot one-to-many competitive game based on the percent of an individual's goal met.
Our research question is whether online community participation can increase adherence to an Internet-mediated walking program, which consists of an uploading pedometer, and going to a website to receive graphical and textual feedback as to whether participants are meeting gradually increasing walking goals. Three hundred participants will spend four months in this randomized, controlled trial to compare the intervention alone to the intervention plus online community support.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Coronary Artery Disease, Obesity
Keywords
heart, weight, Overweight, bmi, diabetes, type 2, diabetic, walk, walk*, diab*, obese, exercise, activity, coronary, pedometer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
324 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Stepping Up to Health only
Arm Title
2
Arm Type
Experimental
Arm Description
Stepping up to Health PLUS online message boards to talk with other participants
Intervention Type
Behavioral
Intervention Name(s)
Stepping Up to Health
Intervention Description
Internet-mediated walking program with pedometers, goal-setting and tailored messaging
Primary Outcome Measure Information:
Title
Total steps
Time Frame
last 30 days of intervention
Secondary Outcome Measure Information:
Title
dropout rate
Time Frame
Four months
Title
days and hours pedometer worn
Time Frame
four months
Title
login frequency
Time Frame
four months
Title
upload frequency
Time Frame
four months
Title
content of posts (qualitative)
Time Frame
four months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must have one or more of the following: Coronary artery disease (CAD); BMI 25 or higher; Type 2 diabetes
Must be sedentary, defined by less than 150 minutes of self-reported activity per week
Must be 18 or older
Must have access to a computer with an Internet connection, a USB port, and Windows 2000 (latest service pack), XP or Vista
Must be a regular email user (checking weekly)
Must be able to communicate in English
Exclusion Criteria:
Pregnant
Cannot walk a block (self-report)
Not competent to sign consent
Unable to obtain medical clearance from a treating physician (primary care, cardiologist, endocrinologist)
Type 1 diabetes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline R Richardson, MD
Organizational Affiliation
University of Michigan Health System Dept. of Family Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
21169160
Citation
Richardson CR, Buis LR, Janney AW, Goodrich DE, Sen A, Hess ML, Mehari KS, Fortlage LA, Resnick PJ, Zikmund-Fisher BJ, Strecher VJ, Piette JD. An online community improves adherence in an internet-mediated walking program. Part 1: results of a randomized controlled trial. J Med Internet Res. 2010 Dec 17;12(4):e71. doi: 10.2196/jmir.1338.
Results Reference
derived
PubMed Identifier
19698154
Citation
Buis LR, Janney AW, Hess ML, Culver SA, Richardson CR. Barriers encountered during enrollment in an internet-mediated randomized controlled trial. Trials. 2009 Aug 23;10:76. doi: 10.1186/1745-6215-10-76.
Results Reference
derived
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Enhancing Adherence by Building Online Communities
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